A new classification approach for identifying and defining the early stages of type 1 diabetes–stages that begin long before symptoms occur– has been endorsed by both the JDRF and the American Diabetes Association (ADA), according to an announcement today in the Diabetes Care journal.

“JDRF and the Association actively worked with several other diabetes foundations,” explains the press release, “including the American Association of Clinical Endocrinologists as well as The Endocrine Society, the Helmsley Charitable Trust, the International Society for Pediatric and Adolescent Diabetes who endorsed the staging approach.”

The Goal: to identify type 1 diabetes before symptoms occur

The goal of this staging model is to clearly identify specific signs that indicate the early development of type 1 diabetes long before DKA (diabetic ketoacidosis) might occur and insulin is needed. Further, with the support of decades of research in identify these early stages, the development of potential therapies and future clinical trials will aim to then prevent the full onset of the disease.

“Finally, the staging approach will provide a framework to help inform benefit/risk evaluation in the regulatory, reimbursement, and clinical care settings,” explains the press release.

“We know type 1 diabetes begins long before insulin dependence occurs, and the best time to halt the disease’s progress is before the loss of insulin-producing pancreatic beta cells,” said JDRF’s Chief Scientific Officer, Richard Insel, M.D. “Decades of research in at-risk individuals have provided the foundation for developing this new three-stage diagnostic approach, which we believe will help optimize the design of clinical trials to prevent symptomatic disease and more quickly evaluate interventions.”

The staging system is the result of recent studies showing that people who test positive for multiple pancreatic islet autoantibodies (defined as Stage 1) have indeed progressed to developing an “intolerance” to glucose, also described as “a disorder of the blood sugar metabolism” because of dysfunctional pancreatic beta cells (defined as Stage 2). These two stages are said to almost always progress to symptomatic type 1 diabetes and the requirement for insulin.

The 3 Stages of Type 1 Diabetes Development:

Stage 2: developing an intolerance to glucose due to dysfunctional pancreatic beta cells

Stage 3: symptoms of type 1 diabetes occur as a result of ketones, lack of insulin, and dangerously high levels of glucose in the blood

“While the rate of progression between stages is variable among individuals, the risk can be defined, which can facilitate clinical trials that aim to preserve functional insulin-producing beta cells.”

Prior to this staging model, type 1 diabetes has never been diagnosed until obvious symptoms occur as a result of stage 3 in the model. Those symptoms include excessive thirst, excessive urination, unexplained weight-loss, fatigue, odorous breath, blurry vision, and sometimes vomiting although this isn’t as common in DKA that has progressed slowly compared to DKA that has progressed quickly from, for example, an insulin pump malfunction in someone already diagnosed.

But who will be tested? And when?

Today one-third of type 1 diabetes diagnosis occur in the emergency room due to severe DKA symptoms. This staging model hopes, for now, to reduce that percentage and catch type 1 diabetes sooner in those believed to be at a higher risk for developing the disease–which is easier said than done.

“Type 1 diabetes is diagnosed relatively late in the disease process. Pre-type 1 diabetes can be identified both in higher risk relatives and the lower risk general population,” said Desmond Schatz, M.D., president-elect, medicine and science at American Diabetes Association. “Using a combination of genetic, immunologic and metabolic markers, distinct categorization of the natural history of the early disease process is now possible. This will facilitate the implementation of specific prevention studies at different stages of the disease process, each with their own distinct endpoints.”

The plan is to focus more closely on people who are close relatives of those living with type 1 diabetes, such as siblings, parents, cousins or grandparents.

Unfortunately, the bigger problem is that type 1 diabetes is not primarily genetically inherited. Nearly 90 percent of the people diagnosed with type 1 diabetes have no history of type 1 diabetes amongst their relatives. This leaves this staging model with a great deal of helpful intention but possibly very little impact in the end.